CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Biomarker Testing Mandate (Medical Coverage Policy)

Administrative policy documenting Rhode Island state-mandated coverage requirements for biomarker testing applicable to BCBSRI commercial products and related provider processes.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBiomarker Testing Mandate (Medical Coverage Policy)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionPrior authorization review may be recommended; consult related policies for services with recommended authorization and coding details.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CommercialApplies to product type

1/1/2024Mandate effective date

CMS NCDs/LCDsExternal coverage sources cited

12Related policy titles

State-Mandated Coverage Criteria for Biomarker Testing

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Coverage criteria: Test is FDA-approved/cleared for the labeled indication or indicated for an FDA-approved drug; OR the test is supported by nationally recognized clinical practice guidelines or consensus statements; OR the test is covered by CMS National Coverage Determinations (NCDs) or Medicare Administrative Contractor (MAC) Local Coverage Determinations (LCDs); and the test provides clinical utility for diagnosis, treatment selection, appropriate management, or ongoing monitoring.

As stated in policy and Rhode Island statute (effective 1/1/2024).

Some employer-sponsored plans are self-funded and may have specific contract terms that modify coverage. Contract exclusions for self-funded groups that have excluded biomarker testing under the Rhode Island mandate apply; in those cases the member’s benefit booklet (Evidence of Coverage or Subscriber Agreement) governs covered services. For self-funded groups with exclusions, a detailed listing of which genetic tests are covered with authorization, considered not medically necessary, or excluded by contract is available in the Coding sections of the related Genetic Testing Services and Proprietary Laboratory Analyses policies. Refer to the benefit booklet to determine whether the member’s plan includes such a customized exclusion.

Genetic testing services that are unlikely to impact therapeutic decision-making or that lack sufficient evidentiary support are considered not appropriate for coverage. Examples include tests where the results would not reasonably be used in patient management, where there is insufficient clinical evidence or strength of recommendation, or where testing is unlikely to change clinical management. Such services may be designated not medically necessary and are subject to denial per policy.

When Biomarker Testing Is Covered

Biomarker testing: clinical utility evidence sources

Covered when the biomarker test provides clinical utility as evidenced by one or more of the following sources:

Evidence of clinical utility: FDA labeling or clearance for the specific test indication or the test is indicated for use with an FDA-approved drug.

FDA-labeled indications referenced in policy statement.

Guideline support: Supported by nationally recognized clinical practice guidelines or consensus statements recommending the test for diagnosis, treatment selection, management, or monitoring.

Policy references nationally recognized guidelines/consensus statements.

CMS coverage: Covered by a CMS National Coverage Determination (NCD) or a Medicare Administrative Contractor (MAC) Local Coverage Determination (LCD) for the intended use.

Policy explicitly includes CMS NCDs and MAC LCDs as evidence sources.

Services Not Covered or Not Medically Necessary

Prior Authorization

Prior Authorization / Documentation Requirements

Provider action: Verify medical necessity and member benefits before ordering genetic testing. Obtain prior authorization when required by the member's plan. Document how test results will be used to guide patient management in the medical record. For self-funded groups that have excluded coverage of biomarker testing under the RI mandate (RI.GL 627-19-81), confirm whether the requested test is a covered service, requires authorization, is considered not medically necessary, or is a contract exclusion by checking the member's Benefit Booklet and the Coding section of the Genetic Testing Services and Proprietary Laboratory Analyses policies.

Check member-specific benefit booklet for customized coverage and contract exclusions (including self-funded groups and RI.GL 627-19-81).
Obtain prior authorization when the plan requires it.
Include documentation of how results will be used to influence clinical management in the patient record to support medical necessity determinations.

Not covered or not medically necessary examples: results that would not reasonably be used in management of the patient; insufficient clinical evidence or weak recommendation; and services unlikely to influence clinical management.

Contract exclusions: Some self-funded groups may exclude biomarker/genetic testing related to state mandates (see RI.GL 627-19-81). For members in those groups the tests are not covered, even if clinically indicated. Confirm coverage status in the member’s Benefit Booklet and the Coding section referenced above.

Related information: See Genetic Testing Services and Proprietary Laboratory Analyses policies for lists of covered, not medically necessary, or excluded tests; follow coding and authorization instructions in those documents.

Provider Responsibilities and Access to Exceptions

Prior Authorization

Prior authorization may be recommended

Prior authorization review may be recommended for certain genetic testing services; consult the Related Policies section for which services recommend authorization and for coding details.

Documentation Required

Make exception request process accessible

Ensure patients and prescribing practitioners have access to the insurer's clear, readily accessible process to request an exception to coverage policy; the process must be made readily accessible on the health insurer’s website.

Note

Exception and prior authorization access

The patient and prescribing practitioner must have access to a clear, readily accessible, and convenient process to request an exception to a coverage policy; follow the insurer's online exception request procedures as posted on their website.

Step Therapy

Provider actions: exception access and recommended prior authorization

Provide patients and prescribing practitioners with information about the exception request process and consult Related Policies for cases where prior authorization is recommended; the statute requires the process be readily accessible on the insurer’s website.

Refer to Related Policies for services that recommend prior authorization and for coding guidance.
Post exception request instructions and links to the insurer’s website resources for patients and prescribers.

Key Terms

Biomarker

DefinitionA characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention.

ExamplesIncludes, but is not limited to, gene mutations and protein expression.

ScopeUsed as the target for testing to inform diagnosis, treatment, management, or monitoring decisions.

Biomarker testing

DefinitionAnalysis of a patient’s tissue, blood, or other biospecimen for the presence of a biomarker.

Included test formatsIncludes single‑analyte tests, multi‑plex panel tests, and whole genome sequencing.

PurposePerforms detection of biomarkers to provide information that may inform clinical decision‑making (diagnosis, treatment, management, or monitoring).

Clinical utility

DefinitionA determination that the test result provides information used in the formulation of treatment or management decisions.

ActionabilityMay include information that is actionable as well as information that cannot be immediately used to formulate clinical decisions.

Role in coverageClinical utility is the standard by which biomarker testing is judged for coverage when it informs diagnosis, treatment selection, management, or monitoring.

Policy Background and Scope

This policy implements Rhode Island statutory requirements that individual and group health policies provide coverage for biomarker testing when it offers clinical utility for diagnosis, treatment selection, appropriate management, or ongoing monitoring. Biomarker testing includes single-analyte tests, multi-plex panels, and whole exome/whole genome sequencing. Clinical utility may be demonstrated by FDA labeling, CMS National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs), or nationally recognized clinical practice guidelines or consensus statements. Coverage is applied in a manner intended to minimize disruptions in care (for example, avoiding the need for multiple biopsies or biospecimen samples) and is subject to plan terms and any applicable contract exclusions.